Big names gamble big bucks on blood tests for early cancer detection

Forget biopsies, ultrasounds, mammograms, pap smears, rectal exams, and other unpleasant cancer screenings—the race is now on for simple, affordable blood tests that can detect all sorts of cancers extremely early.

On Sunday, genetic sequencing company Illumina Inc. announced the start of a new company called Grail, which will join dozens of companies developing such blood tests. Toting big-name investors including Microsoft co-founder Bill Gates and Amazon founder Jeff Bezos, Illumina's high-profile startup raised more than $100 million (£68 million) to get Grail going. The company hopes that Grail’s tests will be on the market by 2019 and cost around $500 (£340) a pop.

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Though researchers have recently questioned the benefits of early cancer screening—showing in some cases that early detection does not generally save lives—Illumina is confident that the science behind the blood-based screens is at least possible. Illumina Chief Executive Jay Flatley, who will be Grail’s chairman, said Illumina has been working on the tests for about a year and a half. "We've made tremendous progress, which gives us the confidence that we can get to the endpoint that we expect."

The blood tests will work by ferreting out specific fragments of DNA or RNA that have escaped from tumors and take laps through the circulatory system. Those roving genetic indicators, called circulating tumor nucleic acids (ctNAs), are then sequenced. Grail and research partners are planning clinical trials that will test ctNA detection on 300,000 people. They also plan to carefully analyze rates of false positives and false negatives—a big problem in many current cancer screenings that can lead to stress, unneeded treatments, or missed opportunities.

Grail will focus on tests for lung and breast cancers first before moving to other forms of the disease including kidney and ovarian.

With some financial experts estimating that the market for blood-based cancer screens could exceed $10 billion (£7 billion) a year, Grail has competition. As Reuters reports, as many as 38 biotech companies are also eagerly working to net effective blood screens for cancer, also called liquid biopsies. Many of those companies have garnered largeinvestments of their own.

But with little data on such tests so far, companies need to proceed cautiously. For instance, a company called Pathway Genomics, Inc. offers a blood test that claims to detect up to 10 types of cancer. That has already been rebuked by the Food and Drug Administration. In a letter to Pathway, the agency wrote: "we believe you are offering a high risk test that has not received adequate clinical validation and may harm the public health.”

Flatley told Reuters that Grail will work with the FDA to avoid such letters and collect all of the clinical data necessary to prove the tests are effective and safe.